The aim of this study is to explore the elementary components in shared goal-setting in patients with no-option CLI. The transcending benefits of this study will apply to doctor-patient communication in general. The primary objective of the study is…
ID
Source
Brief title
Condition
- Other condition
- Vascular injuries
Synonym
Health condition
Patienten met Kritieke Ischemie (Critical Limb Ischemia)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main outcome measure will consist of a list of recurrent themes that
represent the general priorities and preferences of doctors and patients
regarding medical decision-making in patients with no-option CLI.
Secondary outcome
Demographic characteristics, QoL (EQ-5D-5L). The total score on the EQ-5D-5L
will be used as index of quality of life.
Background summary
Medical decision-making is heavily influenced by (unexplored) assumptions from
doctors towards patients and vice versa, rather than by open doctor-patient
communication about (competing) doctor-patient values and priorities. This
highly undesirable situation calls for an approach based on shared goal-setting
(exploring a patient*s values and preferences), as opposed to shared
decision-making (considering only benefits and disadvantages of various
treatments). However, current practice differs from this ideal situation, as no
toolkit is yet available to guide doctors and patients through shared
goal-setting in clinical decision-making. To be able to develop such a toolkit,
this study explores the elementary components of shared goal-setting in a group
of patients with Critical Limb Ischemia (CLI) facing lower-limb amputation.
Study objective
The aim of this study is to explore the elementary components in shared
goal-setting in patients with no-option CLI. The transcending benefits of this
study will apply to doctor-patient communication in general.
The primary objective of the study is to explore which aspects, in terms of
personal values, preferences, and priorities, doctors and patients take into
account when it comes to lower-limb amputation (LLA).
The secondary objective is to explore how doctors and patients experience
shared goal-setting in current practice, and what they perceive as current
facilitators and barriers.
Study design
This qualitative study will use semi-structured interviews to explore important
themes regarding the decisional process preceding the decision whether to
amputate or not. These semi-structured interviews will be conducted with 15
patients, their primary caregivers and 10 vascular surgeons. In patients and
caregivers, demographics, quality of life (EQ-5D-5Ll) negative affect will also
be assessed using validated questionnaires.
Patients treatments regimes will not be changed as a result of study
participation. In total, participation in this study will take approximately
1,5 hour of an individual participant*s time (including first contact,
interview and questionnaires).
Study burden and risks
No risks are involved with participation in the study. The only burden for
participants is the investment of time (max. 1,5h). No direct benefits are
expected to be experienced by the participants.
Wassenaarseweg 52
Leiden 2333 AK
NL
Wassenaarseweg 52
Leiden 2333 AK
NL
Listed location countries
Age
Inclusion criteria
A) For patients (n<=15):
- Age * 18 years old
- Being diagnosed with no-option CLI (no therapeutic possibilities left)
- Frequently visiting the outpatient clinic to consult vascular surgeon for complaints (e.g. weekly);B) For primary caregivers:
- Age * 18 years old
- Having a close relationship with an included patient (e.g. partner, family member, close friend).;C) For vascular surgeons (n<=10):
- Being responsible for the care of CLI patients at the LUMC
Exclusion criteria
For patients (A) and their primary caregivers (B):
-a diagnosis of dementia
- or for other reasons unable to give reliable information (e.g. severe depressive symptoms, psychopathology);C) For vascular surgeons: No exclusion criteria.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL52309.058.15 |